Bavarian Nordic A/S - Interim Report for the Period 1 January to 30... (lable under RFP-2. Theenrolment in this ...)

Bavarian Nordic A/S - Interim Report for the Period 1 January to 30 June 2008

Date:8/19/2008

lable under RFP-2. The enrolment in this arm has also been completed and safety data from this group will be reported in the second half of 2009. Together with a previous HIV study, IMVAMUNE(R) has now been shown to be safe and well tolerated in almost 600 HIV-infected individuals, a population that is contraindicated for traditional smallpox vaccines.

The phase II study in patients diagnosed with AD funded under RFP-2 is currently ongoing and recruitment is expected to be completed by end of 2008. Together with a previous Phase I study, IMVAMUNE(R) has been shown to be safe and well tolerated in 120 subject diagnosed with AD, another population excluded from vaccination with traditional smallpox vaccines.

In the second half of 2008 Bavarian Nordic expects to initiate two Phase II studies. The first study is designed to demonstrate the effect of IMVAMUNE(R) as a booster vaccination (re-vaccination of subjects previously vaccinated with IMVAMUNE(R)) and the second to investigate the safety and immunogenicity of IMVAMUNE(R) in an elderly population.

Anthrax

Preclinical studies are ongoing to evaluate several MVA-BN(R) based anthrax vaccine candidates. Originally MVA-BN(R) encoding the Protective Antigen of Bacillus anthracis, the bacterium that causes anthrax, was planned to enter into a Phase I clinical study in late 2008. However, recent evidence suggests that other MVA-BN(R) anthrax vaccine candidate's offer added benefits in terms of an improved efficacy. Therefore, the planned Phase I study has been postponed, until all Anthrax vaccine candidates have been evaluated in preclinical studies during 2008.

Cancer immunotherapy

The cancer portfolio, which is currently focused on two projects with breast and prostate cancer, was strengthened in the first half of 2008 with the initiation of clinical studies the Company's prostate cancer vaccine candidate. Prostate cancer is, along with breast cancer, in the top three cancer marke
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Bavarian Nordic A/S - Interim Report for the Period 1 January to 30...(lable under RFP-2. Theenrolment in this ...)